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Pfizer and BioNTech on Thursday announced a new trial aiming to test the safety and efficacy of its coronavirus vaccine among pregnant women.
The companies, which together produced one of the two COVID-19 vaccines the Food and Drug Administration approved for emergency use in the U.S., said in a press release that it had given doses to its first group of participants in the new study, which aims to provide clear data on any impacts the inoculation may have for expectant mothers and their newborn children.
William Gruber, senior vice president of Vaccine Clinical Research and Development at Pfizer, said in a statement along with the press release, “We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations.”
Gruber went on to say, “Pregnant women have an increased risk of complications and developing severe COVID-19, which is why it is critical that we develop a vaccine that is safe and effective for this population.”
According to the Centers for Disease Control and Prevention (CDC), pregnant women who are infected with COVID-19 have a higher chance of severe illnesses, including “ICU admission, mechanical ventilation, and death compared with non-pregnant women of reproductive age.”
Pregnant women were excluded from the initial Pfizer-BioNTech clinical trials, and the most updated CDC guidance states that it is a “personal choice” for pregnant women on whether to get the coronavirus vaccine.
Pfizer’s new trial will include about 4,000 healthy pregnant volunteers ages 18 and older who are anywhere from 24 to 34 weeks into their pregnancy, according to Thursday’s press release.
Pfizer and BioNTech said the trial will “evaluate the safety, tolerability, and immunogenicity of two doses” of the vaccine 21 days apart, with half of the participants receiving the actual inoculation and half getting a placebo.
Each woman is expected to participate in the study for seven to 10 months, with researchers looking for any side effects in women, including miscarriage.
The researchers will also monitor the infants until they reach approximately 6 months of age to detect any adverse reactions, as well as the possibility of a vaccinated mother transferring protective antibody to the child while in the womb.
The press release added that those mothers given the placebo will have the opportunity after the study to receive the vaccine.
The additional trial comes as Pfizer, as well as Moderna and AstraZeneca, all have clinical trials underway to determine the safety and efficacy of vaccinations among children, as the inoculations have largely been tested and approved by countries for emergency use for people as young as 16.